Former EPA Chemicals Chief Gives Recommendations for a "Workable and Effective" Chemical Regulatory System

A few days ago I mentioned that advocacy groups highlighted their differences with industry on TSCA reform at a recent chemical industry trade show called GlobalChem. Also presenting at that conference was the former head of the EPA Office responsible for chemicals management, Charlie Auer, now a private consultant. He offered the following "approach elements" on how to move towards a "workable and effective chemical regulatory system in the US."

1) Improved hazard and exposure/use database: a requirement for regular periodic reporting from companies throughout the chemicals value chain to ensure that EPA's understanding of uses/exposures remains current. Auer noted that this should include an Inventory Reset component. He also suggested that there is a need for tiered datasets, i.e., basic data requirements triggered at each level, the ability for EPA to modify basic requirements based on hazard screening results, and a role for SARs, read-across, and other non-animal testing methods.

2) Staged process for risk assessment and risk management: Auer noted that there must be an "open, measured and timely" process in which there must be risk management following risk assessment, a role for periodic reassessment based on new information, consideration of the life-cycle of chemicals, and decisions based on the best available scientific data.

3) Broad risk management authority providing more flexible and effective tools: To include "rule plus order authority" and the ability to require development of enforceable pollution prevention and green chemistry plans.

4) Control actions: To be based on scientifically sound risk assessments, identification of mitigation or prevention measures to ensure safety, and "a determination by EPA that it is reasonable to require such measures."

Auer also suggested that there needed to be better balancing of confidential business information protection and disclosure, legislation that encourages innovation, and greater responsibility by industry throughout the chemicals value chain. He noted that EPA should be directed to regularly update test guidelines to meet current standards and work to achieve by 2020 the NAS "Toxicity Testing in the 21st Century." EPA should also be able to recognize or apply the work done by other governments.

And he, like just about everyone else, noted that EPA must be given adequate resources to do its job. For Auer, that includes adequate funding but also the institution of some sort of chemical registration fee system.

European Chemicals Agency to Publish List of Chemicals Being Registered This Year

According to Geert Dancet, the Executive Director of the European Chemicals Agency (ECHA), the agency will soon publish a list of thousands of high volume and high hazard chemicals it expects to be registered by the November 30 deadline for doing so under the EU's Registration, Evaluation, and Authorization of CHemicals (REACH) regulation.

Dancet encouraged companies that purchase chemicals used in the European market to review the list to be sure the substances they need and ways they use them will be registered. A newly established "Directors' Contact Group" will review the list and is expected to "identify issues of concern and describe feasible, prioritized solutions" by June 1.

ECHA says it has "a general idea of the number of chemicals" it expects to be registered by the deadline, which it anticipates to be around 9,200 chemicals. The big question is the actual number of registrations since a single chemical may be registered by more than one company. ECHA is expecting the number of registrations to range somewhere between 25,000 and 75,000.

All of this has ramifications for TSCA reform in the US as any major problems, or lack thereof, in this first of three REACH registration deadlines will give some indication of the workability of a general data call-in for all chemicals in the US. As noted yesterday, NGOs are strongly in favor of industry providing at least basic data on all chemicals while industry is stongly in favor of EPA first prioritizing to a short list of chemicals for which specific data requests will then be made to industry.

Advocacy Groups Use Chemical Trade Show to Highlight Differences with Industry [UPDATED]

[NOTE: See the Update at the end]

Two of the largest chemical trade associations recently sponsored the chemical industry trade show called GlobalChem. Among the many industry, consultant, and government speakers was Dr. Richard Denison of the Environmental Defense Fund (EDF). Dr. Denison took the opportunity in his talk to highlight where the EDF-sponsored advocacy coalition, Safer Chemicals Healthy Families, differs from industry in the nuts and bolts of TSCA reform.

Denison first noted that 5 years after the deadline for completion of the voluntary HPV Challenge there are still only 60% of chemicals with final submissions. Not a great track record for self-policing in his opinion. He then listed three major differences between what the SCHF Coalition wants and what he characterizes industry to want.

1) SCHF wants data on all chemicals, while industry wants only to provide data on the small subset of chemicals that are of high priority. Industry believes that a REACH-like data call-in for all of the 85,000 chemicals on the current TSCA Inventory is overly burdensome, impossible to manage, and not very productive. Denison believes that data on all chemicals must be obtained so that safe chemicals can be identified for use as substitutes, otherwise you could identify a problem chemical that needs to be banned but have no data on the safety of potential replacements.

2) SCHF wants prompt action on the "most dangerous" chemicals such as those with high hazard, high exposure, PBTs, and those that have already been identified as of higher concern through other programs, while industry wants a long, costly risk assessment process that prolongs study before taking action.

3) SCHF wants to consider multiple sources of exposure, consistent with the recent NAS recommendations, while industry wants to assume that humans and the environment are only exposed to one chemical at a time. Here there is the logistical problem of just how one might go about determining hazard of mixtures but also of determining exposure not only of one chemical from multiple sources but many similar-acting chemicals from multiple sources.

I suppose one could take exception to whether Denison accurately characterized the industry positions, but at the very least it seems he is close enough for argument. There are very real concerns from industry of the burden of a REACH-like program that requires vast resources, both from industry and EPA (REACH created an entirely new 400-person and growing Agency to deal with the data review). There are also very real concerns that without having data for alternative chemicals there is no way of knowing that they are actually "safer" substitutes for obviously hazardous materials. And if there is no exposure, there is no risk, no matter how hazardous a chemical might inherently be. So an accurate assessment is no easy task.

Clearly there is still a lot of work to be done. Hopefully the expected introduction of the Kid Safe Act will give a concrete proposal on which all stakeholders can then base a dialogue. I think that without an actual bill we will simply be dancing around the edges and not getting into the vast differences in the details.

Update: Note that Richard Denison, the subject of this post, has provided additional information in the comment below, including what he calls “the democratization of chemicals management.” Please click on the Comments link below.

The Perils of Plastic (Time magazine article)

Here is an interesting article from Time magazine.

The Perils of Plastic

I'll come back a little later and explore the article further (rushing to and fro lately).

Safer Chemicals, Healthy Families Coalition Rallies Outside Industry Chemicals Conference in Baltimore

A coalition called Safer Chemicals, Healthy Families rallied outside a hotel in Baltimore's Inner Harbor where chemical industry officials were holding a conference this week. A full report in the Baltimore Sun can be read here.

The organization, which is a coalition of environmental, health, children's, worker, and public advocacy groups, has been pressing hard for TSCA chemical reform. The conference, called GlobalChem, heard speakers from industry, NGOs, and even the Executive Director of the new European Chemicals Agency (ECHA) on topics ranging from REACH to international regulations. But mostly it focused on TSCA reform and what industry might expect as Senator Lautenberg moves towards reintroduction of his Kid Safe Chemicals Act.

While Safer Chemicals, Healthy Families was outside, one of the major founders of the coalition, Richard Denison of Environmental Defense Fund, was inside as an invited speaker. Denison, well known to the industry for his very active work on the HPV Challenge program, provided a somewhat different perspective than the industry representatives present. He noted that even 5 years after the voluntary HPV program was "complete," only 60% of the chemicals had actually had full data dossiers provided.

As I mentioned yesterday, there seems to be quite a bit of distance in the details between what the NGOs want to see in a new law and what industry sees. More on this in upcoming days.

TSCA Bill to be Introduced, But Will it Pass?

There seems to be a growing resignation among stakeholders that the long awaited reintroduction of the Kid Safe Chemical Act to update the old Toxic Substances Control Act, while likely to happen soon, may not get through the legislative process in time to be passed in this Congress.

Word from Senator Lautenberg's office is that he still plans to reintroduce the bill within the next few weeks. With Earth Day coming up on April 22nd, that seems like a likely date, especially since then Vice-President Al Gore introduced the High Production Volume (HPV) Chemical Challenge on that date in 1998. It is likely that the Lautenberg bill, and the mirror bill to be introduced by Congressman Rush in the House, will lean toward substantial testing requirements reminiscent of Europe's REACH program. Or not. There seems to be no one who really knows for sure.

And that in itself may be the reason it can't be passed this year. While there has been a great deal of agreement at the 30,000 foot level, there is a great deal of differences once one gets down into the details. NGOs would like industry to have to provide some base set of data on every single chemical on the TSCA Inventory (approximately 85,000). That is what REACH is doing now in Europe. Industry believes that EPA should somehow prioritize chemicals and then ask for specific data for that subset of specific chemicals that have the highest priority. And that is a fundamental difference that could take some substantial time to resolve, especially given the widely partisan nature of Congress at the moment.

So, it seems more and more likely that the bill will be a starting point for intense discussions between Congress, industry, NGOs, and other stakeholders, which will occur throughout the rest of this year. Then the potentially highly revised bill would have to be reintroduced (for the 4th time) in the next session of Congress. And given the likelihood that the November elections will significantly alter the balance of power in Congress, the delay could mean a lot.

Or not. :)

More to come.

Is TSCA Chemical Control Reform Ever Going to Happen?

Last year at this time Senator Lautenberg intimated that a new Kid Safe bill that reforms the 34 year old Toxic Substances Control Act was "imminent." The same word has been used many times since then, and still no bill has been introduced, though several House and Senate hearings have been held in recent months.

The latest is that the bill will be introduced by Senator Lautenberg sometime after the Congressional recess that starts today and runs through April 9th. Congressman Rush will introduce a mirror bill in the House. Given the current timing, it seems possible that the bill might be held a couple of more weeks for an April 22nd (Earth Day) introduction.

But introduction of the bill doesn't mean it will pass this year. Already much of Congress has shifted into campaign mode for the November elections, and with the likelihood of significant Republican seat gains in both houses, there seems to be little incentive for the minority party to speed things up on TSCA reform. Likewise, many Democrats are wary of any effort that might be negatively impact their reelection campaigns. In recent remarks to the Environmental Council of the States (ECOS), the head of the EPA toxics office, Steve Owens, suggested that it was "unlikely" that much would happen on any bill now introduced, even though both industry and advocacy groups are pushing for "modernization" of TSCA.

More info tomorrow!

New "Natural Products" Certification

The Natural Products Association, a Washington-based group representing manufacturers and retailers including Clorox Co. and Whole Foods Market, released new standards last month for natural home care products. It seems that there is concern that products like household cleaners and detergents can say on they are natural on their labels when in fact they are made mostly of synthetic ingredients. So NPA issued guidelines, and products that meet those standards will be able to display the association's seal (see above).

Most people think that natural means that the product's ingredients are derived from renewable resources like plants and minerals. But believe it or not, NPA is the first to issue a uniform standard among manufacturers for use of the word in home-care products.

To display the seal, products will have to meet criteria that include:

- 95% of the ingredients in the product, excluding water, must be derived from natural sources.

- non-natural ingredients should be used only when alternative natural ingredients are unavailable.

- the product should contain no ingredients with suspected human health risks.

NPA says it is reviewing full ingredient lists from manufacturers who have applied for certification to determine whether their products qualify. The seal will be seen on products in the next several months.

More information can be found at the NPA site.

EPA Set to Post More Chemical Action Plans - Bisphenol A and Benzidine Dyes

EPA appears to be taking seriously its commitment to produce "action plans" for chemicals it feels need to be more closely regulated. In December 2009 it issued action plans for four chemicals, and now they are preparing action plans for Bisphenol A (BPA) and Benzidine dyes. Both of these were listed in the September 29, 2009 outline of Administrator Jackson's "comprehensive approach to chemicals management," along with the four noted in the December action plans (phthalates, long-chain chlorinated paraffins, PBDEs, and perfluorinated chemicals).

The action plans for BPA and benzidine dyes will be posted on EPA's website shortly. Like the earlier ones, the new action plans may include listing of chemicals that pose a concern using Section 5(b)(4) of TSCA authority, Section 6 limitations, Section 4 test rules, and incorporating Design for the Environment activities.

In addition, EPA is announcing four more chemicals that will be the subject of upcoming action plan development, which EPA anticipates releasing in late spring. Those four are:

NP/NPE (nonylphenol/nonylphenol ethoxylate)
HBCD (hexabromocyclododecane)
Siloxanes
Diisocyanates

Finally, EPA is also in the process of developing a list of potential chemicals for future action plan development and anticipates making that information available this summer.

So while a TSCA reform bill may be imminent, it will likely take some time before a bill reaches the House and Senate floors for a vote, and then there will be a transition period before the new requirements come into force. In the meantime, EPA is using all the authority it believes it already has under TSCA, something that perhaps it wasn't doing so robustly in the past.

GAO Report on Protecting Children from Environmental Threats - Senate Hearing

As reported yesterday, the Senate held a hearing entitled "Hearing on the Government Accountability Office’s Investigation of EPA’s Efforts to Protect Children’s Health." EPW Committee Chair Senator Boxer never quite made it to the meeting, but it was ably chaired by Senator Amy Klobuchar who chairs the new subcommittee on children's health. The focus of the hearing was on a new GAO report requested by Congress, and testimony was heard from representatives from EPA and GAO as well as NIOSH, the Children's Environmental Health Network, and the Science and Environmental Health Network. Full testimony can be found at the hearing site link above.

The full GAO report was also released yesterday and can be found at the hearing site. A PDF can also be found here.

The GAO report concludes that "EPA has developed policies and guidance to consider children, but it has not maintained attention to children through agency strategies and priorities." It notes that while "[i]n 1996, EPA created a national agenda on children’s health, and its 1997 and 2000 strategic plans highlighted children’s health as a key cross-agency program," that early momentum was lost during the previous decade. GAO notes that "EPA has not updated the agenda since 1996, and the focus on children is absent from the 2003, 2006, and September 2009 draft strategic plans."

Furthermore, GAO concludes that "EPA has not fully used the Office of Children’s Health Protection and other child-focused resources. The active involvement of managers from the office and experts from the Children’s Health Protection Advisory Committee has been lacking, as has the involvement of key staff throughout EPA." GAO noted that there seems to be a renewed emphasis under the new administration, but that "[a]lthough EPA now has a new Director of Children’s Health, the office had not had consistent leadership since 2002, hampering its ability to support and facilitate agencywide efforts and elevate matters of importance with senior officials. For example, a previous director established workgroups to bring together officials from the program offices and the children’s health office, but a subsequent acting director eliminated these groups, effectively halting work on a key set of children’s health recommendations. In addition, the regional children’s health coordinators—who provide outreach and coordination for EPA—have no national strategy or dedicated resources. Finally, the advisory committee has provided hundreds of recommendations, but EPA has requested advice on draft regulations only three times in the last decade."

GAO further concludes that despite the critical need for EPA leadership in "protecting children from environmental threats, EPA’s efforts have been hampered by the expiration in 2005 of certain provisions in the executive order. For example, the Task Force on Children’s Environmental Health provided EPA with a forum for interagency leadership on important federal efforts, such as the National Children’s Study. It also provided biennial reports that helped establish federal research priorities."

In short, emphasis on children's health was severely lacking during the last 10 years and while the current administration has taken many steps to reemphasize this issue, more needs to be done.

Based on the questioning yesterday, and Senator Klobuchar's personal interest in children's health (similar comments were also made by Senators Lautenberg and Bill Nelson), it seems clear that the new TSCA reform bill will emphasize the "Kid Safe" component of chemical regulation.

Senator Barbara Boxer Hearing on Protecting Children's Health and TSCA

Senator Barbara Boxer is holding a hearing today, March 17, 2010 entitled, "Hearing on the Government Accountability Office’s Investigation of EPA’s Efforts to Protect Children’s Health." While not billed as part of the TSCA reform effort specifically, clearly this hearing is related as the key focus on the new chemical contol bill is likely to be on the protection of children from chemical exposure. Hence the "Kid Safe" moniker of the bills introduced in previous Congresses by Senator Frank Lautenberg.

The Government Accountability Office’s (GAO) is often called on by Congress to look at various issues, and John Stephenson (see below) is a frequent witness relaying the results of GAO investigations. Today's hearing will look at the GAO's evaluation of the Environmental Protection Agency’s (EPA) children’s health program. The committee will also examine what can be done to strengthen protections for children. In addition, Senator Bill Nelson (D-FL) is also expected to give testimony on the federal government’s role in investigating children’s health issues and how that can be improved.

Witnesses scheduled to testify include:

Panel 1

Peter Grevatt Ph.D. - Director, Office of Children’s Health Protection and Environmental Education, United States Environmental Protection Agency

John Stephenson - Director, Natural Resources and Environment, U.S. Government Accountability Office

Panel 2

Gina Solomon M.D., M.P.H. - Associate Director of the UCSF Pediatric Environmental Health Specialty Unit, Center for Occupational & Environmental Health, University of California at Berkeley

Cynthia F. Bearer M.D., Ph.D. - Board Chair, Children’s Environmental Health Network

Ted Schettler M.D. - Science Director, Science and Environmental Health Network

The hearing is being held in the Environment and Public Works Hearing Room, 406 Dirksen Senate Building, Washington DC. It also is expected to be webcast live.

In a Move Towards Transparency, EPA Makes the TSCA Inventory Freely Accessible to the Public

I have mentioned the TSCA Inventory here many times. Well, now the EPA has announced that it is making the Inventory available to the public, free of charge, on the internet. Previously it was accessible only by purchasing it from the NTIS library or other databases. By making it free on its website, EPA is taking "another step to increase the transparency of chemical information while continuing to push for legislative reform of the 30 year old TSCA law."

The TSCA Inventory can be accessed here.

The currently Invenotry lists more than 84,000 chemicals manufactured, used, or imported in the United States. About 17,000 of these are protected by confidential business information claims and cannot be included in the free database at this point. However, EPA has already begun taking a series of aggressive steps to provide greater transparency on chemical risk information. I mentioned one such step several weeks ago that noted EPA’s intent to reduce at least one type of CBI claim.

Next steps at increasing transparency include adding TSCA facility information and the list of chemicals manufactured to the Facility Registry System to the freely available information. The FRS is a database that with these additions will provide the public with information on the facilities in their communities using industrial chemicals.

So while the march towards TSCA reform continues in Congress, EPA also continues to work within its current TSCA authority to improve the transparency and safety of chemicals.

European NGOs Press the European Commission for Action on PBTs, Candidate List and Authorization for REACH

A group of NGOs have written to the European Commission in an attempt to prod them for progress on three key issues under the REACH regulation that they believe are not moving quickly enough. According to one of the NGOs, ChemSec:

The main issues of concern include the Commission proposal on the criteria for the inclusion of persistent, bioaccumulative and toxic ((PBT) chemicals, the lack of progress on the REACH Candidate List and the delay in starting the Authorisation process.

The letter was addressed to Antonio Tajani and Janez Potocnik, respectively new EU Commissioner for Industry and Entrepreneurship and new EU Commissioner for the Environment. On March 25, 2010 the two Commissioners will visit the European Chemicals Agency in Helsinki, and the goal of the letter was to "express concern regarding the delayed progress of REACH implementation."

Related to the concerns about the decision on the PBT criteria (REACH Annex XIII), the groups "refer to our detailed letter to the Commission on this issue from 5 December 2008" and conclude that "the Commission has so far ignored expert advice from Member States, scientists and NGOs to ensure that all relevant information is considered in the PBT/vPvB identification." The NGOs believe that "the Commission’s proposal from 2008 does nothing to change the criteria," and thus "fail to address the problem of increasing contamination of people and wildlife with persistent, bioaccumulative and toxic chemicals."

The NGOs also "deplore the lack of progress on the REACH candidate list," which "more than two years after entry into force," "only contains 29 officially recognised substances of very high concern compared to 478 substances identified by a group of Member States as meeting the official REACH criteria and the 356 substances on the NGO SIN List 1.1 (“Substitute it Now!)”. The NGOs urge the Commission and ECHA to "dedicate more resources to speed up the substitution of substances of very high concern, including hormone disrupting substances."

Finally, they believe that there has been undue delay in starting the authorisation procedure. They remind the Commission that it "has not taken action on the seven prioritised substances of very high concern recommended by ECHA" back in June 2009. The NGO's say that this is "simply unacceptable."

Whether the letter will influence speedier action will remain to be seen. ECHA and the Commission have been quite busy dealing with the registration process (the "R" in REACH) while continuing to try to build up the staff in Helsinki. Clearly there is a lot on the Commission's, and certainly on ECHA's, respective plates. Which perhaps gives all the more importance to NGOs and other organizations pressing for forward movement.

The signators of the letter were from WWF European Policy Office, Centre for International Environmental Law, ChemSec, CHEMTrust, European Environmental Bureau, Greenpeace, Health & Environment Alliance and Women in Europe for a Common Future. The full letter can be read here.

European Chemicals Agency Proposes 8 New Chemicals as REACH Substances of Very High Concern (SVHCs)

The European Chemicals Agency (ECHA), located in Helsinki, Finland, has published new proposals to classify eight chemicals as substances of very high concern (SVHC). These substances now are listed on the candidate list, which is the first step toward possible inclusion on Annex XIV of REACH, which is the Authorization list. Substances making it to the Authorization Annex will be banned unless the manufacturer or importer applies for authorization, which if accepted would allow them to keep certain essential uses on the market for a short period of time while alternatives are being developed.

Commenting on the proposals for the eight substances is open until April 22, 2010.

All eight of the substances are listed because they meet the criteria for being CMRs, that is, substances that are carcinogenic (C), mutagenic (M), and/or reproductive toxins (R). The eight chemicals are:

Ammonium dichromate (Category II for C, M and R)

Anyhdrous disodium tetraborate (Category II for R)

Boric acid (Category II for R)

Potassium chromate (Category II for C and M)

Potassium dichromate (Category II for C, M and R)

Sodium chromate (Category II for C, M and R)

Tetraboron disodium heptaoxide hydrate (Category II for R)

Trichloroethylene (Category II for C)

Proposals are introduced to ECHA by member states, and the above were offered by Denmark, France and Germany. The candidate list for Authorization already has 29 substances, to which these 8 could be added pending the results of the commenting period. The last list had 15 substances on it, but one was removed after being the subject of a lawsuit that successfully challenged the applicability of the Authorization process for intermediates.